Product code PBK

Device name: Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set
Medical specialty: Microbiology
Device class: 2
Regulation number: 866.3315
Review panel: MI
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Ineligible
Definition: In vitro qualitative detection of non-variola Orthopoxvirus nucleic acids extracted from human specimens or viral culture.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K222558	Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set	Centers for Disease Control and Prevention	2022-08-30
K221834	Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set	Centers for Disease Control and Prevention	2022-06-24
K221658	Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set	Centers for Disease Control and Prevention	2022-06-10
DEN070001	NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET	Centers for Disease Control and Prevention	2018-09-21
K181205	Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set	Centers for Disease Control and Prevention	2018-09-20

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